Abstract
Rheumatoid arthritis (RA) is a chronic inflammatory joint disease causing joint dysfunction; reduction of quality of life (QoL); loss of work ability, self-care ability, and executing daily routines in most patients 5–10 years after the disease onset. Objective. To study QoL and the functional status (FS) of Russian RA patients receiving tocilizumab (TCZ). Material and Methods. The study involved 42 patients with verified RA diagnosis (moderate or high activity) who had earlier undergone inefficient therapy with basic anti-inflammatory medications. The limitation of the FS of the RA patients was determined quantitatively using the Russian-language version of the HAQ questionnaire. QoL was evaluated using the EuroQol-5D (EQ-5D) Quality of Life questionnaire prior to treatment and after 4, 8, 12, 16, 20, and 24 weeks. Results. TCZ therapy demonstrated a rapid improvement of the FS of RA patients with a 64% decrease in the HAQ index (ΔHAQ=1.12), which corresponded to a 50% improvement of the health status of patients according to the ACR criteria. The median value [25th; 75th percentile] of the EQ-5D index was 0.52 [-0.02; 0.52]; 27.7% patients assessed their QoL as “worse than death”. The index reliably increased by week 8 of therapy; there were no patients with the negative EQ-5D index by week 24. Depending on QoL, all the patients were subdivided into two groups. Group 1 (n=12) comprised the patients with the EQ-5D no higher than 0; in group 2 patients (n=30), it was higher than 0. The groups were comparable in terms of disease duration, age, disease activity indices, and the previous treatment. The low QoL index in all 12 patients in group 1 was attributed to the infeasibility of performing daily activities and the reliably higher pain level (75.0 [61.0; 86.0] and 66.0 [48.0; 71.0] in groups 1 and 2, respectively; p=0.02). Improved QoL and reduced pain level were observed in both groups as early as after the first TCZ infusion. By week 24, the pain level decreased to 26.5 [11.0; 24.0] and 10.0 [2.0; 31.0] in groups 1 and 2, respectively. The EQ-5D index in group 1 became positive by week 8 of therapy. Conclusion. TCZ therapy quickly improves the FS and QoL of RA patients, including those with the most severe condition.
Highlights
Ревматоидный артрит (РА) – хроническое воспалительное заболевание суставов, приводящее к нарушению их функции, снижению качества жизни (КЖ), потере трудоспособности, возможности самообслуживания и выполнения действий в повседневной жизни у большинства больных через 5–10 лет от начала заболевания
TCZ therapy demonstrated a rapid improvement of the functional status (FS) of Rheumatoid arthritis (RA) patients with a 64% decrease in the HAQ index (ΔHAQ=1.12), which corresponded to a 50% improvement of the health status of patients according to the ACR criteria
The index reliably increased by week 8 of therapy; there were no patients with the negative EQ-5D index by week 24
Summary
Ограничение ФС больных РА определялось количественно с использованием русской версии опросника HAQ; оценка КЖ производилась при помощи опросника оценки качества жизни EuroQol-5D(EQ-5D) до лечения и через 4, 8, 12, 16, 20, 24 нед. На фоне терапии ТЦЗ наблюдалось быстрое улучшение ФС больных РА со снижением индекса HAQ на 64% (ΔHAQ=1,12), что соответствовало 50% улучшению состояния здоровья больных по критериям Американской коллегии ревматологов (ACR). Целью настоящего исследования было изучение динамики КЖ и ФС больных РА на фоне терапии ТЦЗ в группе российских пациентов. Эта работа проводилась в рамках 24-недельного исследования IV фазы «Локальное Открытое многоцентровое исследование оценки качества жизни пациентов с умеренной или высокой активностью Ревматоидного артрита и НЕадекватным ответом на базисные препараты при добавлении к терапии Тоцилизумаба (ЛОРНЕТ)». Уже через 4 нед после первой инфузии выявлено достоверное уменьшение индекса HAQ с 1,75 [0,69; 2,38] до 1,19 [0,88; 1,63], превышавшее МКЗИ (медиана ΔHAQ=0,56). К 24-й неделе медиана индекса достигла 0,63 [0,13; 1,13] (рис. 3), что соответствовало снижению на 64% (ΔHAQ=1,12), выраженному улучшению ФС больных и 50% улучшению по критериям ACR
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